Synthes (USA) Products LLC
99 recalls on record · Latest: Oct 29, 2025
FDA Devices Moderate Oct 29, 2025
LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA…
FDA Devices Moderate Jun 5, 2024
STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic surgery. Par…
FDA Devices Moderate Mar 13, 2024
Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
FDA Devices Moderate Mar 13, 2024
RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (…
FDA Devices Moderate Mar 13, 2024
13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle de…
FDA Devices Moderate Mar 13, 2024
TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S
FDA Devices Moderate Mar 13, 2024
1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S
FDA Devices Moderate Mar 13, 2024
VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part Number: 02.112.621S
FDA Devices Moderate Mar 13, 2024
2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S
FDA Devices Moderate Mar 22, 2023
TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. …
FDA Devices Moderate Mar 22, 2023
TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. …
FDA Devices Moderate Oct 26, 2022
SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
FDA Devices Moderate Oct 26, 2022
DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001
FDA Devices Moderate May 18, 2022
Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm.…
FDA Devices Moderate Feb 16, 2022
Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" Tibial Nailin…
FDA Devices Moderate Dec 23, 2020
DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.020S
FDA Devices Moderate Dec 23, 2020
DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.019S
FDA Devices Moderate Dec 23, 2020
DePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.026S
FDA Devices Moderate Dec 23, 2020
DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.022S
FDA Devices Moderate Dec 23, 2020
DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument Part Code: 03.404.028S
FDA Devices Moderate Dec 23, 2020
DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.029S
FDA Devices Moderate Dec 23, 2020
DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.021S
FDA Devices Moderate Dec 23, 2020
DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.025S
FDA Devices Moderate Dec 23, 2020
DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.018S
FDA Devices Low Nov 11, 2020
END RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495.394 - Product Usage: is a vertebral body replacement device for the cervica…
FDA Devices Low Nov 11, 2020
END RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495-398 - Product Usage: is a vertebral body replacement device for the cervica…
FDA Devices Low Nov 11, 2020
SYNMESH¿ 22MM X 28MM 88MM HEIGHT (TI) Product Number: 495.379 - Product Usage: is a vertebral body replacement device for the cervical, thoracic an…
FDA Devices Low Nov 11, 2020
STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar …
FDA Devices Low Nov 11, 2020
END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar s…
FDA Devices Low Nov 11, 2020
3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and…
FDA Devices Low Nov 11, 2020
SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lu…
FDA Devices Low Nov 11, 2020
SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lu…
FDA Devices Moderate Aug 26, 2020
DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of fractures, osteotomies and non-…
FDA Devices Moderate Nov 20, 2019
MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle Trial Spacer 10mm with T-Handl…
FDA Devices Moderate Oct 31, 2018
3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Screws are intended for fixat…
FDA Devices Moderate Jun 27, 2018
Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set
FDA Devices Moderate Jun 27, 2018
Part no. 690.380, Graphic Case F/7.3mm Cannulated Screw Set
FDA Devices Moderate May 30, 2018
Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation.
FDA Devices Moderate May 16, 2018
Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623
FDA Devices Moderate May 16, 2018
Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630
FDA Devices Moderate Mar 14, 2018
2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
FDA Devices Moderate Mar 14, 2018
Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
FDA Devices Moderate Mar 14, 2018
2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
FDA Devices Moderate Feb 21, 2018
11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
FDA Devices Moderate Mar 8, 2017
PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. Part numbers 03.820.350 and 03.820.352. Used to hold the disc segment…
FDA Devices Moderate Dec 28, 2016
Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument
FDA Devices Moderate Dec 7, 2016
Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
FDA Devices Moderate Nov 30, 2016
Extraction Hook - Sterile for TI Cannulated Nails
FDA Devices Moderate Nov 30, 2016
3.0 mm Guide Rod/950 mm with Smooth Tip, sterile
FDA Devices Moderate Nov 30, 2016